Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about ? On this page you'll find 537 study documents about .
Page 4 out of 537 results
Sort by
![SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers](/docpics/5482412/6657e227bde20_5482412_121_171.jpeg)
-
SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers
- Exam (elaborations) • 10 pages • 2024
- Available in package deal
-
- $11.99
- + learn more
SOCRA Practice Test Certification Final 
Exam Questions with 100% Correct 
answers 
Which of the following is a disclosure of financial interests form? - CORRECT 
ANSWER-FDA Form 3455 
Which of the following is a certification of financial interest form? - CORRECT 
ANSWER-FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit 
the following form: - CORRECT ANSWER-FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginnin...
![SOCRA Certification Exam Guide 2024 with correct answer](/docpics/5482401/6657e1a94196b_5482401_121_171.jpeg)
-
SOCRA Certification Exam Guide 2024 with correct answer
- Exam (elaborations) • 16 pages • 2024
- Available in package deal
-
- $14.49
- + learn more
SOCRA Certification Exam Guide 2024 
with correct answer 
Does the FDA consider electronic signatures to be as trustworthy and reliable as 
handwritten paper signatures? - CORRECT ANSWER-Yes (although permission to use 
such e-sigs has to be approved by the FDA) 
Does the FDA consider electronic records that meet requirements to be equivalent to 
handwritten records ? - CORRECT ANSWER-Yes 
Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by 
people who are responsible...
![CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024](/docpics/5482393/6657e16b2a073_5482393_121_171.jpeg)
-
CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024
- Exam (elaborations) • 7 pages • 2024
- Available in package deal
-
- $12.49
- + learn more
CCRP SoCRA Exam Cert Exam 
Questions with Verified Answers 2024 
21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 
21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 
21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 
21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human 
Subjects 
21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in 
Clinical ...
![SOCRA Certification Exam Questions and Answers 2024 100% Correct](/docpics/5482382/6657e0f9564bd_5482382_121_171.jpeg)
-
SOCRA Certification Exam Questions and Answers 2024 100% Correct
- Exam (elaborations) • 13 pages • 2024
- Available in package deal
-
- $12.99
- + learn more
SOCRA Certification Exam Questions 
and Answers 2024 100% Correct 
Biometrics - CORRECT ANSWER-A method of verifying an individual's identity based 
on measurement of the individual's physical features or repeatable actions where those 
features and or actions are both unique to that individual and measurable. (21 CFR, 
Sec. 11.3) 
Closed System - CORRECT ANSWER-An environment in which system access is 
controlled by persons who are responsible for the content of electronic records that a...
![SOCRA UPDATED Exam Questions and CORRECT Answers](/docpics/5458204/66555d222dc49_5458204_121_171.jpeg)
-
SOCRA UPDATED Exam Questions and CORRECT Answers
- Exam (elaborations) • 13 pages • 2024
- Available in package deal
-
- $8.49
- + learn more
Which of the following is a disclosure of financial interests form? - FDA Form 3455 
Which of the following is a certification of financial interest form? - FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit the 
following form: - FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - 
Investigational New Drug Application (1571) 
In the top right corner, form have OMB number. What does it stand ...
![SOCRA TOP Exam Guide Questions and CORRECT Answers](/docpics/5458203/66555d1f46d3f_5458203_121_171.jpeg)
-
SOCRA TOP Exam Guide Questions and CORRECT Answers
- Exam (elaborations) • 25 pages • 2024
- Available in package deal
-
- $8.99
- + learn more
When isn't an IND application needed? - IND Application is not needed if investigation 
does not support change in labeling. 
What information must the general IND include? 
(21 CFR Part 312.23) - -FDA Form 1571 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investigative Plan 
-Investigator's brochure 
-Protocol 
-Chemistry/Manufacturing information 
-Pharmacology/Toxicology 
-Previous human research/literature information 
-Additional information (drug dependence and abuse potential)
![SOCRA PASSED Exam Questions and CORRECT Answers](/docpics/5458201/66555d1c63ac2_5458201_121_171.jpeg)
-
SOCRA PASSED Exam Questions and CORRECT Answers
- Exam (elaborations) • 16 pages • 2024
- Available in package deal
-
- $8.99
- + learn more
Respect for persons, justice, beneficence - List the three ethical principles of the 
Belmont report 
Experiment that involves a test article and one or more human subjects - does not include 
experiments which are nonclinical lab studies - Define clinical investigation 
Someone who is or becomes A participate in research either as a recipient of the test article or 
as a control - Human subject is: 
Life threatening circumstances deem use of test article necessary, inability to communicate o...
SOCRA EXAMS BUNDLE| Questions with 100% Correct Answers
![SOCRA (CCRP) Exam Practice Questions and Answers 2024](/docpics/5434194/6651de4a44e9a_5434194_121_171.jpeg)
-
SOCRA (CCRP) Exam Practice Questions and Answers 2024
- Exam (elaborations) • 2 pages • 2024
-
- $7.99
- + learn more
The Belmont Report's principle of respect for persons incorporates at least two ethical 
convictions: first, that individuals should be treated as autonomous agents, and second, 
that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to 
protection. 
Which of the following is an example of how the principle of beneficence can be applied 
to a study employing human subjects? - CORRECT AND ANSWER-Determining that 
the study has a maximization of benefits and a minimization ...
![SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers](/docpics/5434181/6651ddda68450_5434181_121_171.jpeg)
-
SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers
- Exam (elaborations) • 10 pages • 2024
-
- $7.99
- + learn more
Which of the following is a disclosure of financial interests form? - CORRECT 
ANSWER-FDA Form 3455 
Which of the following is a certification of financial interest form? - CORRECT 
ANSWER-FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit 
the following form: - CORRECT ANSWER-FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - 
CORRECT ANSWER-Investigational New Drug Application (1571) 
In...
![Verkoop je kennis op stuvia](https://www.stuvia.com/hosted-imgs/app/stock-fotos/banner_seller_big.jpg)
How much did you already spend on Stuvia? Imagine there are plenty more of you out there paying for study notes, but this time YOU are the seller. Ka-ching! Discover all about earning on Stuvia